UL and Stryker Develop Bone Repair Material
Researchers at the University of Limerick, in collaboration with research & development staff at Stryker, have developed the world’s first FDA cleared injectable Hydroxyapatite forming bone repair material used in neurosurgical procedures.
DirectInject™ is a Calcium Phosphate Cement (CPC) which is used to fill bone defects caused by surgical procedures, for example in brain tumour excision surgery, or as a result of trauma.
Traditional products on the market in this area are all based on powder and liquid format, where the surgeon mixes the powder and liquid and transfers the mixed cement into a delivery syringe prior to usage. This mixing process has to be performed in the operating room (OR) as the mixture rapidly sets and is unusable after just a short period, the new product transforms that timeline. Dr Eamonn de Barra, University of Limerick explains “This invention saves critical time for surgeons in theatre as the new formulation enables mixing and application in the delivery syringe while ensuring no impact on the performance of the product. In neurosurgery in particular, saving nearly 10 minutes in a procedure has major benefits for patient outcomes.”
The innovative product was launched by Stryker this year and is already in use in US hospitals since November. DirectInject™ is currently undergoing regulatory approvals for a variety of other global jurisdictions. The projected annual sales revenue of this product manufactured in Ireland is US$20 million.
Steve Harris Director of Stryker R&D said: “We are delighted with the clinical feedback received from neurosurgeons throughout the US. As the first and only true on-demand HA bone cement, DirectInject™ has revolutionised neurosurgery, providing the surgeon with a precision, rapid delivery option that reduces the risk of intra-operative complications associated with traditional bone cement mixing and delivery systems. The R&D talent base available in Ireland has been a crucial factor in the success of this product development.” Dr de Barra added: “The success of this industry/academic partnership has wider benefits for the R&D landscape in Ireland as this product is directly supporting 20 high value jobs in Limerick and the potential for further developments in the future.”
This research was undertaken by researchers involved in the Bernal Project and the Health Research Institute at the University of Limerick and is funded by the Irish Research Council under their Enterprise Partnership Scheme.